Irrigation line, Bien Air

GUDID 08056646504930

Tube set sterile S600 (10/pkg)

OMNIA SRL

Disposable surgical irrigation/aspiration system

• Primary Device ID: 08056646504930
• NIH Device Record Key: 354ad956-fe91-48ad-b892-6e4c9aafc62d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrigation line, Bien Air
• Version Model Number: 32.F0241.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646504930 [Unit of Use]
GS1	08056646504947 [Primary]

FDA Product Code

• EFS: Unit, Oral Irrigation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-17
• Device Publish Date: 2021-08-09

Devices Manufactured by OMNIA SRL

• 08056646509966 - Irrigation Set: 2024-11-19
• 08056646509980 - Irrigation Set: 2024-11-19
• 08052141311400 - Irrigation line, Kavo: 2023-08-16 Sterilizable Hose Set S600
• 08052141311424 - Irrigation line, Kavo: 2023-08-16 Hose set for Kavo INTRASurg (10/pkg)
• 08052141310014 - Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u: 2023-07-06 Transparent bag 67x75 cm with sliding ties for physiodispensers or for control units
• 08056646505739 - Omnicover: 2023-07-06 Round waterproof headrest cover Ø 22 cm with elastic Shell Cover
• 08056646505890 - Universal seat cover and backrest cover Shell Cover: 2023-07-06 Universal seat cover and backrest cover Shell Cover
• 08056646508563 - Transparent drape 40x50 cm with adhesive tape for physiodispensers or for contro: 2023-07-06 Transparent drape 40x50 cm with adhesive tape for physiodispensers or for control units